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1 Sep
The 2021 annual law for market and competition addressing, as to the healthcare sector, reimbursement of drugs, intermediate distribution, patent linkage and institutional accreditation of private healthcare facilities entered into force on 27 August
The 2021 annual law for market and competition addressing, as to the healthcare sector, reimbursement of drugs, intermediate distribution, patent linkage and institutional accreditation of private healthcare facilities entered into force on 27 August
16 Nov 21
Draft competition bill: New rules for the healthcare sector?
On November 5, 2021, the Council of Ministers approved the draft law on competition. The Competition Bill is now under review by Parliament, which will discuss the draft in the coming weeks.
14 Sep 21
Pharmaceutical company liability in clinical trials: The italian supreme court’s latest decision
On April 20, 2021, the Italian Supreme Court dealt with a complex and much debated matter: pharmaceutical company liability for damages to a participant in a sponsored clinical trial.
12 Apr 21
The Italian Medicines Agency provides additional information on the new simplified classification procedure for generics and biosimilars
The Italian Drug Agency (AIFA) provided further information on the new simplified pricing and reimbursement procedure introduced in October 2020 for generics and biosimilars.
3 Dec 20
Generic and biosimilar medicines: Italian Medicines Agency adopted a new simplified pricing and reimbursement procedure
On October 15, 2020, the Italian Medicines Agency (Agenzia Italiana del Farmaco – “AIFA”) published a new simplified pricing and reimbursement procedure for generics and biosimilars.
9 Apr 19
EU General Court provides guidance to assess whether patent settlements between originator and generics infringe antitrust law (Servier)
On 12 December 2018 the General Court of the EU (“GC”) has passed a set of parallel judgments (we will referrer to Case T-691/14,Servier and Others v. Commission and Case T-684/144,Krka v. Commission) on the incompatibility with Article 101 TFEU of a number of settlement agreements in patent disputes between Servier, which is the originator of Perindopril (a drug primarily intended for the treatment of hypertension and heart failure), and five manufacturers of that drug’s generic versions.
Welcome to the Portolano Cavallo Life Sciences blog focusing on legal development and key legal issues affecting the life sciences and healthcare industry.
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Our highly-ranked team of professionals will provide news, insights and multidisciplinary commentary on the hottest and most recent regulatory, transactional and contentious aspects of the pharmaceutical, bio-tech, med-tech, food supplement and healthcare world with an eye on its digital transformation and technological developments.

This blog will be a place for focusing on digital health, telemedicine and artificial intelligence, as well as more traditional topics: from the protection of intellectual properties to performance of clinical trials, from the market access to advertising and competition issues, from internal and criminal investigations to M&A and venture capital transactions.

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September 21, 2022
Payback for medical devices: Decree quantifying the exceeding of the expenditure ceiling for medical devices at national and regional level for the years 2015, 2016, 2017 and 2018 published ...
September 1, 2022
The 2021 annual law for market and competition addressing, as to the healthcare sector, reimbursement of drugs, intermediate distribution, patent linkage and institutional accreditation of p...
July 19, 2022
Guidelines for the implementation of the Electronic Health Record (EHR) to ensure dissemination, uniformity and accessibility of the EHR at national level now published in the Official Gazet...
June 6, 2022
The National Coordination Centre for Ethics Committees published new draft agreements for conducting clinical trials on drugs and medical devices
April 27, 2022
EU Medical Device Coordination Group (MDCG) approves “Guidance” on the borderline between medical devices and medicinal products in order to support the uniform application of Regulation...
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